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Bluejay Diagnostics meets Oct. 23, 2026 site deadline
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Fusion42 · 14 October 2026 · Fusion42 review
Bluejay Diagnostics has completed the establishment of a manufacturing site for its Symphony™ cartridges ahead of the October 23, 2026 deadline under its license agreement with Toray Industries, with the site located at SanyoSeiko Co., Ltd. in Japan. The Symphony™ IL-6 Test remains an investigational device and has not received FDA clearance for commercial use in the United States.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
Your medtech product’s path to FDA clearance just tightened. The manufacturing milestone shows Bluejay’s move to scale, signalling that competitors with investigational devices face pressure to secure production before regulatory approval.
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1 source · 13 Oct 2026
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